An Allergan whistleblower lawsuit alleges the manufacturing company sold defective Lap Band weight loss products, and marketed the medical devices for procedures not recommended or necessary.

The Allergan whistleblower lawsuit alleges various violations of nthe False Claims Act (FCA), stating that these misleading marketing statements had caused expensive and unnecessary claims to be filed to federal healthcare concerns like Medicaid.

The company is now paying $3.5 million to settle the Allergan whistleblower lawsuit.

The suit was filed under the whistleblower provision of the False Claims Act. This act allows private parties, such as employees or other individuals who witnessed the fraud, to file a qui tam lawsuit on behalf of the federal government.

The whistleblowers in this case were Monte S. and Ryan T., a surgeon from Arizona and a former Allergan account manager for the state of Arizona respectively.

Overview of Allergan Whistleblower Lawsuit

This Allergan whistleblower lawsuit was filed back in 2008, when sales representatives and healthcare professionals had reported serious lap band device defects to the company.

The Allergan Lap Band is a weight loss product, which is a gastric band system that is surgically implanted in the patient’s stomach. These devices were approved to treat adult patients suffering from obesity, and are supposed to constrict the stomach to reduce appetite. The devices consist of an “access port,” in which fluid is added before being implanted.

Even though these devices are supposed to help adult patients suffering from persistent obesity, the Allergan whistleblower lawsuit alleges there were injury reports indicating port leak problems. The federal government became involved in the case between January 2008 and November 2010, and stated Allergan Inc. was fully aware of the problems associated with the defective ports.

According to the Allergan whistleblower lawsuit, Ryan had first reported these problems in August 2008 when Schwartz, a customer of Ryan’s, had reported problems with the Lap Band ports. Ryan was allegedly fired not long after reporting the incident in August 2010, which later spurred him to file this Allergan whistleblower suit with Monte.

The federal government furthermore alleges that between 2008 and 2012, Allergan Inc. had pushed for the Lap Band device to be used in procedures not approved by the FDA. The company had allegedly tried to persuade doctors to prescribe them using free lunches and dinners that were provided at demonstration events for the product.

The Allergan whistleblower lawsuit ultimately alleges the company knew about their product’s defects, but had concealed the problem to guarantee high sales. Not only was this problematic to patients, this also caused the federal government money in false claims for allegedly unnecessary medical procedures.

“Rather than addressing the leaking port defects by reporting the defective device to the FDA and proposing to remedy the defect, Allergan senior officials sought to deflect concerns of surgeons and patients and to hide knowledge of a significant rate of failure in the ports from the leakage,” the Allergan whistleblower lawsuit states.

The civil settlement portion of the Allergan whistleblower settlement is $3,300,360, and Maryland state Medicaid share is $199,640. For their roles as whistleblowers, Monte and Ryan will receive approximately $590,000 from the settlement.

This Allergan Whistelblower Lawsuit is Case No. 1:10-cv-02796, in the U.S. District Court for the District of Maryland.